Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The FDA calls on your CDMO; inspectors are fortified by data in AI models, and appear practically clairvoyant. “It won’t be like the ‘old days,’” says David Grote of GrayMatters Partners, an organization that advises on quality systems and inspection readiness. The agency earlier rolled out Elsa, an AI-enable data architecture. Now its added an impressive HALO - Harmonized AI & Lifecycle Operations for Data.

GUEST COLUMNISTS

Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
US Pharma Reshoring: The Full Policy Timeline
As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

PHARMA OUTSOURCING WHITE PAPERS

Challenges And Solutions In Lyophilization Development For ADCs
Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

Controlling Complexity In ADC Formulation Development
ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.
Insights And Effective Strategies For A Successful Technology Transfer
Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.
Advancing Chronic Care Through GLP‑1 Innovation
GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
Biocapacitance Measurement: A PAT Tool For Biomass Measurement In An Upstream Process
Leverage process analytical technologies (PAT) to gain real-time insight into product quality, strengthen control strategies, and build more efficient, scalable manufacturing processes for future success.
Achieving Unmatched Accuracy And Compliance In Pressure Sensing
Discover how advanced pressure sensing can improve measurement accuracy, simplify system design, and support more efficient, sustainable bioprocessing.